Veteran additive manufacturing experts in orthopaedics say that just five years ago, they would not have predicted today’s adoption rate of additive nor companies’ advancement of the technology. OEMs and suppliers are investing millions in additive manufacturing, with products entering the market every month. The technology’s potential across orthopaedics remains exciting and, we believe, unknown.
We say exciting because additive is being adopted by orthopaedic companies of all sizes, across multiple market segments. And if realized, the benefits of the technology—a better product for the patient and surgeon and a cost sensitive manufacturing process—may help to achieve healthcare’s demands for the foreseeable future.
We say unknown because questions remain unanswered. Device companies continue to develop new designs and push the technology in ways that additive machine companies themselves hadn't expected. Additionally, companies throughout the orthopaedic supply chain that have decades of additive experience are joining the call for increased standards and guidance. This call is partially driven to ensure that additive is employed and advanced in a way that won’t harm patients and ultimately the industry, and partially because companies seek to substantiate their additive processes. Outstanding questions pertain to significant topics like material standardization, process validation, design limitations and cleanliness recommendations.
To learn about the real opportunities and headwinds that companies have faced with additive manufacturing, here we recap a panel conversation from OMTEC 2018 with 4WEB Medical, K2M and LimaCorporate. Not surprisingly, no matter which manufacturing process you use, each brings its own set of challenges that you may not have considered in your adoption of the technology.
Giving and Taking on Design Specs
Jennifer Moore, Senior Project Engineer, K2M
K2M was investigating alternative material interbody implants, from ceramics to different metals and polymers, when it adopted additive manufacturing. It took the company a little more than two years from design input to FDA 510(k) clearance and CE Mark approval, which K2M received for its Lamellar Titanium Technology for interbody systems in 2015.
Much is talked about the design freedom that additive manufacturing allows. Moore argues against the idea that additive can be used for any device design. The correct approach is to design to the technology you plan to use. For example, during the panel, Moore and Jessee Hunt of 4WEB noted that they use different additive processes and machines, and their companies' individual designs cannot be manufactured on the technology that the other company uses.
K2M outsources all of its manufacturing. Like any manufacturing relationship, Moore stresses there must be close collaboration with your supplier to ensure manufacturability of your design. K2M searched literature to determine the best surface roughness for its Lamellar implants. The company zeroed in on a couple of micron surfaces and then identified the best type of additive to support their findings.
Moore said, “It’s a lot of working together with the supplier and their specific machines. When we’re coming up with the ideas, all of the design requirements, we have to give and take a little bit because of the effective resolution of the machines and then the cleaning. For spine interbodies, you want bone to grow into and around the cage for fusion. We were trying to put in features specifically to enhance bony in-growth and on-growth. We had to adjust the features in the cage, and we relied on the technical expertise of our partner companies. It’s give and take.”
Moore's Request for Future Additive Technology Developments: I would focus on printer resolution—getting features that are close to the CAD model out of the gate. Figure out how to print without support materials.
Demanding Quality of Process and Products
Michele Pressacco, Dr.-Ing., Research & Development Director, LimaCorporate
LimaCorporate started using additive in 2005 and received a CE Mark for its first application, an acetabular cup, in 2007. The company’s Trabecular Titanium technology has extended from hip to extremities and patient-specific solutions. Today, about 50% of LimaCorporate’s revenue is derived from additively manufactured implants, says Pressacco. The company’s use of additive manufacturing is highly integrated in house, with few exceptions such as purchasing powder and software from suppliers.
When prioritizing quality management, Pressacco acknowledges issues in manufacturing of legacy products, as well as balancing validation costs, capacity and machine upkeep.
“The biggest challenge that we have with a product that has a long clinical history is finding a way to make exactly the same product with the evolution of the machine.
“To be able to get the same design that we developed in 2007, we had to downgrade the newest machine, which had higher capability, to be sure that we provide a consistent product to our customer. This historically has been one of our biggest challenges together with the validation cost and the validation time. We are strongly vertically integrated with our manufacturing in house.
“Today, every time there is a new release of a new machine, the validation is not straightforward despite the fact that we have more than 10 years of knowledge.
“We aim to contain the validation cost, but at the same time provide enough capacity to operations to properly run production. The biggest challenge, in my opinion, that we’re still missing is in regard to software to be able to control this aspect. I’ve wanted software that goes from CAD down to the machine, which I believe is becoming more and more critical. Also looking at the FDA guidance, they are paying a lot of attention to the translation from one software to another, and now you manipulate the software and you make sure that you keep track of the changes. Obviously having one tool that gives you the ability to integrate everything, I believe, would be a significant addition.”
Pressacco's Request for Future Additive Technology Development: An integrated solution from CAD directly to the machine, possibly integrating into a PLM software. Also, software that gives you the capability to control different machines located at different sites in accordance with the validation.
Seeking Shorter Lead Times
Jessee Hunt, Founder, 4WEB Medical
Hunt founded 4WEB Medical in 2008, and in 2011, the company received its first 510(k), which represented the first FDA clearance of an additively manufactured spine implant. As more companies adopted additive manufacturing, lead times with 4WEB’s suppliers got longer. To solve part of the problem, 4WEB brought some of its manufacturing in house by acquiring machines and hiring a company to run them in order to avoid overhead costs. Orthopaedics is experiencing a bottleneck to get products on market due to the growing number of device companies seeking to utilize additive and outsource the manufacturing to a small number of suppliers.
Hunt says that capacity—the number of machines to produce additive parts—will be one of the larger obstacles industry will face in the next five years.
“A lot of people don’t understand what it takes to print a product family and then be able to scale. You can’t say, ‘I have one machine and it’s going to print 10,000 parts this year; we’re good to go.’ If you have 60 part numbers in a product family and you only have one machine, that would take 60 days to get through one production build to be able to put that product family on the market—that’s not acceptable.
“Four or five companies each quarter are popping up saying, ‘I need my 3D-printed parts.’ There are only a few companies that are specialized to be able to do medical device. It’s a significant investment. The amount of time it takes to get a machine input and qualified and then set up for production and then parts through the full production process, whether you like it or not, is a 12-month process.
“How much do you invest and how many pieces of equipment do you invest in when you have a bunch of companies that don’t know how many implants they’re going to sell? There’s a lot of guess work going into this and the number of machines to be able to support the number of companies that are moving in this direction is going to cause a big challenge early on.”
Hunt's Request for the Future: We want efficiency of lead time from print to finish to get it out to market. I don’t want 16 weeks; I want 8 weeks.
Editor’s Note: Maximilian Munsch, Dr.-Ing., Co-Founder and Managing Partner at Ampower, moderated the OMTEC panel with Hunt, Moore and Pressacco. After the discussion, we asked him his thoughts on the adoption of additive manufacturing by orthopaedic companies, as well as what he finds exciting and of concern. His response follows.
Additive manufacturing is now an established production technology in orthopaedics. Over recent years, a variety of additive manufacturing applications were successfully introduced to the market: cement-free joint replacements with highly porous implant/bone interface, patient specific instruments or customized endoprostheses for revision and tumor surgery. These applications often do not only yield a clinical benefit, but also lower the total manufacturing cost compared to traditional supply chains of similar products.
With more than 20 years of extensive research and development and 10 years of clinical history, powder bed fusion with laser or electron beam is now the prevalent technology for metal components. The early adopters of these production technologies greatly benefited from their competitive advantage. Having recognized the potential, the innovators invested at an early stage to understand the processes, develop new unique features and learn how to overcome barriers. Early market entry followed and allowed a strategic positioning of product families. The pioneering OEMs show a continuous increase of additive manufacturing products in their portfolio. This indicates high market demand, and also success.
The strong focus on powder bed fusion continues. However, parallel technology developments should not be overlooked. New additive manufacturing technologies are on the horizon, such as binder jetting of metal materials. The promise of high production speeds at low costs of potentially biocompatible materials poses an immense untapped potential, and will have a tremendous impact on today’s additive manufacturing value chains. It remains to be seen who will benefit from the next potential shift of state of the art in production technology.
*Article image is 4WEB Medical's Lateral Spine Truss System. Image courtesy of 4WEB Medical.
Carolyn LaWell is ORTHOWORLD’s Chief Content Officer. She can be reached by email.